Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-09-20

Brief Summary

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Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed for many years and extensively used for pain management following abdominal surgeries such as laparotomies and appendicectomies. Erector Spinae Plane Block (ESPB)-first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries. Intrathecal opioid administration is an attractive analgesic technique since the opioid is injected directly into the cerebrospinal fluid, close to the structures of the central nervous system where the opioid acts.

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Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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G1 Group: (Erector Spinae Plane Block (ESPB) Group)

Group Type ACTIVE_COMPARATOR

Ultrasound Guided Erector Spinae Plane Block

Intervention Type PROCEDURE

General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive bilateral ultrasound-guided ESPB by the an experienced anesthetist in US regional blocks, with each block 20 mL of bupivacaine 0.25%

G2 Group: (Intra thecal morphine (ITM) Group)

Group Type ACTIVE_COMPARATOR

Intra thecal morphine.

Intervention Type DRUG

General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive intra thecal morphine with spinal needle 25G, 3 ml containing 300 ug preservative free morphine

G3 Group: (Control Group)

Group Type OTHER

General anesthesia using intravenous fentanyl (1µgm/kg)

Intervention Type DRUG

Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg)

Interventions

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